Trial record 3 of 642 for:    "Cystic Fibrosis"

Assessment of Quadriceps Muscle Electrostimulation Used in Patients Suffering From Cystic Fibrosis (STIMUCO)

This study has been terminated.
(enrolment difficulties)
Sponsor:
Collaborator:
Vaincre la Mucoviscidose
Information provided by:
University Hospital, Grenoble
ClinicalTrials.gov Identifier:
NCT00391703
First received: October 23, 2006
Last updated: November 10, 2010
Last verified: November 2010
  Purpose

This is an add-on, randomized, open label, clinical trial that evaluates the use of quadriceps electrostimulation as an additional retraining procedure in patients suffering from cystic fibrosis.


Condition Intervention
Cystic Fibrosis
Mucoviscidosis
Behavioral: Electrostimulation programme: using a cycloergometer
Behavioral: Usual sport activity

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Assessment of Quadriceps Muscle Electrostimulation Used as an Additional Procedure for Effort Retraining in Patients Suffering From Cystic Fibrosis Associated With Severe Pulmonary Dysfunction

Resource links provided by NLM:


Further study details as provided by University Hospital, Grenoble:

Primary Outcome Measures:
  • The six-minute walking distance [ Time Frame: 0, 1, 2 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Cycloergometer test: maximum power, maximum oxygen consumption, minute ventilation [ Time Frame: 1 month ] [ Designated as safety issue: No ]
  • Inspiratory reserve volume (IRV), gasometry, dyspnea score [ Time Frame: 0, 1, 2 months ] [ Designated as safety issue: No ]
  • Measurement of voluntary maximum force and non cooperative force of the quadriceps [ Time Frame: 0, 1, 2 months ] [ Designated as safety issue: No ]
  • Area of quadriceps cross section measured with a scanner [ Time Frame: 1, 2 months ] [ Designated as safety issue: No ]
  • Quadriceps muscle mass [ Time Frame: 0, 1, 2 months ] [ Designated as safety issue: No ]
  • Quality of life: CFQ14, BDI-TDI questionnaires [ Time Frame: 0, 1, 2 months ] [ Designated as safety issue: No ]
  • Compliance with ergocycle rehabilitation [ Time Frame: 1 month ] [ Designated as safety issue: No ]
  • HOMA and QUICKI tests [ Time Frame: 0, 1, 2 months ] [ Designated as safety issue: No ]
  • Spirometry [ Time Frame: 0, 1, 2 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: October 2006
Study Completion Date: September 2010
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Quadriceps electrostimulation program, performed prior to an endurance retraining program using a cycloergometer
Behavioral: Electrostimulation programme: using a cycloergometer
Quadriceps electrostimulation programme performed prior to an endurance retraining program using a cycloergometer, for 6 weeks, 60 to 90 minutes by session, 5 to 6 sessions per week
Active Comparator: 2
Usual sport activity, performed prior to an endurance retraining program using a cycloergometer
Behavioral: Usual sport activity
Usual sport activity performed prior to an endurance retraining program using a cycloergometer

Detailed Description:

Cystic fibrosis is an autosomal recessive genetic disease due to a mutation of the CFTR protein gene. The CFTR protein transports chloride ions (Cl-) across cell membranes in the lungs, pancreas, digestive tract, reproductive tract, and skin.

CFTR mutation mainly leads to a dysfunction of the pulmonary system and pancreas exocrine function.

Several studies showed that cystic fibrosis commonly induces a reduction of effort tolerance, peripheral muscular strength and work capacity.

Patients suffering from cystic fibrosis with a high endurance capacity have a lower risk of poor prognosis. Those with a severe dyspnea have a higher benefit with a force training or a combined force and endurance training than with endurance training alone.

We propose to study the effect of a quadriceps electrostimulation program, performed prior to an endurance retraining program using a cycloergometer, in patients with cystic fibrosis associated with severe pulmonary dysfunction, to enhance their muscular performance and increase their adherence to the cycloergometer retraining program.

This is a randomized trial with two groups:

Group A: experimental group, twenty patients. Six weeks with electrostimulation program followed by six weeks under a cycloergometer program.

Group B: control group, twenty patients. Six weeks with their usual physical activity followed by six weeks with a cycloergometer program.

The Randomization is stratified on expiratory volume per second. The size of randomization blocks is random because of the open design.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age >= 18 years
  • Patient suffering from cystic fibrosis
  • Patient has at least three measures of maximum expiratory volume per second <= 45% of the theory among the 6 last measures performed
  • Affiliation to French social security
  • Capacity to consent

Exclusion Criteria:

  • Pregnant women
  • Contraindication to application of magnetic field
  • Pacemaker
  • History of neurosurgical intervention
  • Presence of metallic particles near the stimulation site.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00391703

Locations
France
Pneumology Department of Grenoble University Hospital
Grenoble, Isere, France, 38043
Pneumology Department of Lyon University Hospital
Lyon, Rhone, France, 69000
Sponsors and Collaborators
University Hospital, Grenoble
Vaincre la Mucoviscidose
Investigators
Study Director: Claire Cracowski, Dr Pneumology Department of Grenoble University Hospital
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: M. Eric Svahn, Clinical Research Department, Grenoble University Hospital
ClinicalTrials.gov Identifier: NCT00391703     History of Changes
Other Study ID Numbers: DCIC05/31
Study First Received: October 23, 2006
Last Updated: November 10, 2010
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by University Hospital, Grenoble:
Cystic fibrosis
mucoviscidosis
electrostimulation
retraining

Additional relevant MeSH terms:
Cystic Fibrosis
Fibrosis
Stress, Psychological
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Pathologic Processes
Behavioral Symptoms

ClinicalTrials.gov processed this record on August 01, 2014